Process Engineer 1 (Downstream Engineering)
Location: Holly Springs
Posted on: June 23, 2025
|
|
|
Job Description:
FUJIFILM Diosynth Biotechnologies is building the future of
bioproduction in Holly Springs, North Carolina. By end of 2025,
we’ll open North America’s largest end-to-end CDMO
biopharmaceutical manufacturing facility, offering drug substance
production, fill-finish, and packaging under one roof. We’re
looking for passionate, mission-driven people to help us realize
this exciting vision and deliver the next vaccine, cure, or
therapy. We offer a dynamic work environment and we’re proud to
cultivate a culture that will fuel your purpose, energy, and
drive—what we call Genki. Ready to shape the future of medicine?
Let’s transform healthcare together! Holly Springs, North Carolina,
combines small-town warmth with proximity to Raleigh’s thriving
tech scene, making it the perfect blend of community and
opportunity. What Youll Do • Supports on time delivery and ensures
quality from Fujifilm and Engineering, Procurement, Construction
Management (EPCM) provider • Supports piping and instrumentation
diagram (P&IDs) and other process design document review •
Provides input to detailed design activities in partnership with
EPCM provider • Writes User Requirement Specifications (URSs) •
Supports Factory Acceptance Testing (FAT), Commissioning
Qualification, and Validation (CQV), and start-up activities with
supervision • Serves as on-call support for process equipment •
Reviews, redlines, and approves P&IDs and other technical
documents with supervision • Contributes to system impact
assessments and quality risk assessments for process equipment •
Supports technology transfer (TT) activities related to process
equipment • Supports execution of Good Manufacturing Practices
(GMP) runs • Provides technical support for root cause analysis
(RCA) and process deviation investigations • Assists with
deviations, change controls, corrective and preventive action
(CAPA) closures • Supports technical risk assessments for new
manufacturing equipment • Provides on-floor manufacturing support
for equipment issues • Cross-trains on unit operations to assist
team with meeting deliverables • Collaborates with other
departments, such as Quality, Manufacturing, Maintenance,
Validation, and Safety. • Other duties, as assigned Minimum
Requirements • Bachelor’s degree in Chemical Engineering,
Biotechnology Engineering, or another related field • 0-1 years of
engineering or other relevant technical work experience Preferred
Requirements • Experience working in a cGMP environment or other
highly regulated industry • Prior experience with mammalian cell
culture processes Working & Physical Conditions • Will work in
environment which may necessitate respiratory protection • May work
in Mechanical/Production spaces that may require hearing protection
and enrollment in a hearing conservation program. • Ability to
discern audible cues. • Ability to ascend or descend ladders,
scaffolding, ramps, etc. • Ability to stand for prolonged periods
of time up to 120 minutes. • Ability to sit for prolonged periods
of time up to 240 minutes. • Ability to conduct activities using
repetitive motions that include wrists, hands or fingers. • Ability
to operate machinery and/or power tools. • Ability to conduct work
that includes moving objects up to 33 pounds. • Ability to bend,
push or pull, reach to retrieve materials from 18" to 60" in
height, and using twisting motions. • Will work in warm/cold
environments (60-90 range). • Will work in small and/or enclosed
spaces. • Will work in heights greater than 4 feet.
Keywords: , Danville , Process Engineer 1 (Downstream Engineering), Engineering , Holly Springs, Virginia
